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510(k) K834239

SDI C-FLEX STERILE LIGHT HANDLE by Sterile Design, Inc.

K834239 is an FDA 510(k) premarket notification submitted by Sterile Design, Inc. for the device "SDI C-FLEX STERILE LIGHT HANDLE". The FDA issued a decision of Substantially Equivalent on April 25, 1984. Sterile Design, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
December 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Sterile Design, Inc.

  • K934688 — STERILE DESIGN (March 16, 1994)
  • K841960 — CARDIO METRICS INVASIVE PRESSURE MONIT (November 8, 1985)
  • K842356 — CUSTOM STERILE PROCEDURE KITS (March 21, 1985)
  • K841959 — CARDIO METRIC CUSTOM PERFUSION TUBING (October 19, 1984)
  • K842351 — STERILE DESIGN-CUSTOM STERILE IV KIT (October 15, 1984)
  • K841958 — CARDIO METRICS CARDIOTOMY RESERVOIR (October 15, 1984)
  • K834237 — GRADUATED GUIDE WIRE BOWL 8 (February 4, 1984)
  • K813437 — PAN SET (December 31, 1981)
  • K791738 — CUSTOM DRESSING CHANGE TRAYS (October 2, 1979)

FDA data resources